BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS

    MDR report key: 3202971 · Received July 2, 2013

    Report

    Report Number
    2015691-2013-20512
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    June 4, 2013
    Report Date
    June 5, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P000007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE NOT RETURNED. THE DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE DONE BECAUSE THE SERIAL NUMBER IS UNKNOWN. THE DEVICE CANNOT BE RETURNED FOR EVALUATION BECAUSE IT WAS DISCARDED BY THE HOSPITAL. DATE OF IMPLANT WAS REPORTED ONLY AS ¿LATE 2006¿, THEREFORE, THE IMPLANT DURATION AND AGE OF THE DEVICE ARE UNKNOWN. IMPLANT DURATION IS APPROXIMATELY 6-1/2 YEARS. THERE ARE MANY FACTORS THAT COULD RESULT IN THE NEED TO EXPLANT AND REPLACE A VALVE, THE MOST COMMON OF WHICH ARE REGURGITATION OR STENOSIS CAUSED BY PANNUS AND/OR CALCIFICATION. THESE COMPLICATIONS CAN HAVE MANY ROOT CAUSES, INCLUDING BUT NOT LIMITED TO PATIENT FACTORS, (AGE, DISEASE STATES, COMORBIDITIES), PHARMACOLOGICAL FACTORS, OR PROCEDURE FACTORS. IT IS TYPICALLY NOT RELATED TO PRODUCT MALFUNCTION. ALTHOUGH THERE ARE MULTIPLE ROOT CAUSES, VALVES ARE TYPICALLY EXPLANTED BECAUSE THEY ARE NOT FUNCTIONING OPTIMALLY. IN THIS CASE, THE SURGEON INDICATED THIS DEVICE WAS EXPLANTED DUE TO REGURGITATION AND THE CONDITION OF THE DEVICE AT EXPLANT WAS DESCRIBED AS HAVING A ¿BIG HOLE IN LEFT CORONARY CUSP AND A SMALL HOLE IN RIGHT CORONARY CUSP¿, THE CAUSE OF WHICH IS UNKNOWN AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. ADDITIONALLY, THE PATIENT¿S ASCENDING AORTA WAS ALSO REPLACED AND HAD A PREVIOUS HISTORY OF STENOSIS. WITHOUT RETURN OF THE DEVICE FOR EVALUATION, WE ARE UNABLE TO DETERMINE ROOT CAUSE FOR EXPLANT OF THIS DEVICE.

    Description of Event or Problem · 1

    REPORTEDLY, A 25MM VALVE WAS EXPLANTED DUE TO AORTIC REGURGITATION (AR). THE CUSTOMER REPORTED A 25MM VALVE WAS IMPLANTED TO CORRECT AORTIC STENOSIS (AS) IN LATE 2006. FROM LATE 2012, WHILE THE PATIENT WAS BEING MONITORED, AORTIC REGURGITATION HAD DEVELOPED. ON (B)(6) 2013, THE DEVICE WAS EXPLANTED AND REPLACED WITH A 20MM AORTIC VALVE. A REPLACEMENT OF THE ASCENDING AORTA WAS ALSO PERFORMED DURING THE SAME SURGERY. AT EXPLANT, A BIG HOLE IN THE LEFT CORONARY CUSP AND A SMALL HOLE IN THE RIGHT CORONARY CUSP APPEARED TO BE OBSERVED AND THEY WERE LIKELY DUE TO AGED DETERIORATION. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION BECAUSE IT WAS DISCARDED AT THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300914 EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 2500P

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| R